Diabetic Gastroparesis Efficacy/Safety Study of TZP-102

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Diabetic Gastroparesis

In brief

The purpose of this study is to test the safety and effectiveness of 10 mg TZP-102 given prior to meals three times a day compared to placebo (capsule that looks like active study drug but contains no active drug), administered for 12 weeks, in diabetic subjects with symptoms associated with gastroparesis.

Key facts

Study ID

NCT01664637

Run by

Tranzyme, Inc.

People needed

120

Starts

2012-08-01

Expected to finish

2013-02-01

Last updated by the study team

2012-12-20

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18 to 80 years of age inclusive
• Type 1 or type 2 diabetes mellitus
• History of symptoms of gastroparesis for at least 3 months leading up to the Screening Visit
• Documented delayed gastric emptying
• Upper gastrointestinal obstruction ruled out by endoscopy or barium scan
• Concomitant medications must be stable for at least 2 weeks leading up to the Screening visit and must be maintained during the study.
• Females of child-bearing potential must have a negative serum pregnancy test and use (and agree to continue to use throughout the study) an acceptable form of contraception

You may not qualify if…

• Gastrectomy, bariatric surgery, fundoplication or vagotomy/pyloroplasty
• Has had or plans to have endoscopic pyloric injections of botulinum toxin within 6 months prior to the Screening Visit or during the study
• NG, PEG or PEJ feeding tube or inpatient hospitalization for gastroparesis within 2 weeks prior to the Screening Visit
• Required parenteral nutrition for treatment of gastroparesis within 2 months prior to the Screening Visit
• Active gastric pacemaker within 3 months prior to the Screening Visit

Where it is running

• Tranzyme Investigational Site — Huntsville, Alabama, United States
• Tranzyme Investigational Site — Tucson, Arizona, United States
• Tranzyme Investigational Site — North Little Rock, Arkansas, United States
• Tranzyme Investigational Site — Long Beach, California, United States
• Tranzyme Investigational Site — Ventura, California, United States
• Tranzyme Investigational Site — Hialeah, Florida, United States
• Tranzyme Investigational Site — Inverness, Florida, United States
• Tranzyme Investigational Site — Jacksonville, Florida, United States
• Tranzyme Investigational Site — Miami, Florida, United States
• Tranzyme Investigational Site — Miami, Florida, United States
• Tranzyme Investigational Site — New Smyrna Beach, Florida, United States
• Tranzyme Investigational Site — Anderson, Indiana, United States
• Tranzyme Investigational Site — Indianapolis, Indiana, United States
• Tranzyme Investigational Site — Kansas City, Kansas, United States
• Tranzyme Investigational Site — Monroe, Louisiana, United States
• Tranzyme Investigational Site — Boston, Massachusetts, United States
• Tranzyme Investigational Site — Mexico, Missouri, United States
• Tranzyme Investigational Site — Raleigh, North Carolina, United States
• Tranzyme Investigational Site — Salisbury, North Carolina, United States
• Tranzyme Investigational Site — Winston-Salem, North Carolina, United States
• Tranzyme Investigational Site — Oklahoma City, Oklahoma, United States
• Tranzyme Investigational Site — Portland, Oregon, United States
• Tranzyme Investigational Site — El Paso, Texas, United States
• Tranzyme Investigational Site — Bialystok, Poland
• Tranzyme Investigational Site — Bialystok, Poland

Full record on ClinicalTrials.gov

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